Kornimate/medical-research-clean huggingface dataset:
feasibility study of a molecular karyotype using a very high-throughput sequencing approach, the "massive parallel sequencing" on circulating tumor dna

Conditions: Breast Cancer; Colo-rectal Cancer

Summary: there are several types of circulating dna: dna from patient's existing cells, foetal dna in the case of pregnant woman, and tumoral dna in the case of patients with cancer. these circulating tumoral dna (ctdna) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the massive parallel sequencing technique (mps). this study focus on using this technique on breast and colorectal cancers in which no analysis of cnv (tumor origin marker) with this technique has been performed yet. it is a prospective, pilot, monocentric, feasibility study on genomic profile. the study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctdna with the mps approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by cgh array (comparative genomic hybridization) from primitive tumor.


Eligibility criteria:
inclusion criteria: * age \> 18 years * signed consent * women with invasive breast carcinoma, nos, with a radiologically measurable tumor of more than 10 mm (stade i to iii) * patients with invasive colorectal adenocarcinoma with a radiologically measurable tumor of more than 10 mm (stade i to iii) * patients who primary surgery is planned exclusion criteria: * neoadjuvant chemotherapy or neoadjuvant radiotherapy * other cancer * bmi \> 30 * pregnant woman * patients under protective administration or deprived of liberty

Keywords: ctdna molecular karyotype
safety of treatment initiation with biphasic insulin aspart 30 in hospitalised patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (novomix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * treated with oral anti-diabetics and/or human insulin exclusion criteria: * persons previously included in the trial * hypersensitive to biphasic insulin aspart or any of the excipients * pregnant or lactating women, or those who plan to get pregnant within the next 12 months
surgically induced astigmatism of temporal versus nasal clear corneal phacoemulsification

Conditions: Surrgical Induced Astigmatism

Summary: to compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

in a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. surgically induced astigmatism (sia) was calculated by the vector analysis method using the holladay-cravy-koch formula. patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism \>1d, pseudoexfoliation and any corneal pathology were excluded.

Eligibility criteria:
inclusion criteria: * all the patients with senile cataract exclusion criteria: * previously operated eyes * presence of corneal pathology * pseudo exfoliation * with-the-rule (wtr) astigmatism \>1 d * presence of diabetes mellitus * history of connective tissue disease * consumption of systemic steroids

Keywords: kataract astigmatism phacoemulsification
the impact of receptive music therapy in the icu

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether music therapy has an effect on pain, agitation, and vital signs of patients in the intensive care unit (icu) when compared to usual care. music therapy is an intervention provided to patients after a referral by a nurse or attending physician. patients will be assigned to two groups. the intervention group will receive 1 30 minute music therapy intervention provided by a board certified music therapist (mt-bc). the music therapy intervention will consist of a relaxation experience with live music presented by the mt-bc on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. vital signs, pain, and agitation are collected pre and post. patients assigned to the control group will receive usual care for a patient in the icu. vital signs, pain, and agitation will be collected.


Eligibility criteria:
inclusion criteria: * 18 years of age or greater * on a mechanical ventilator exclusion criteria: * airborne and special contact isolation * non english or spanish speaking lars * pregnant * prisoners * brain dead * unstable bradycardia or hypotension * patients who have been referred to music therapy with a goal of stimulation.
influence of drug transporter expression on the pharmacokinetics of the hiv protease inhibitor kaletra

Conditions: Healthy; Pharmacokinetics

Summary: the aim of this study is to determine the pharmacokinetics of kaletra™ (hiv protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (mdr, mrp1, mrp2 and bcrp) in the tissue distribution of the two protease inhibitors. the latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (pbmcs) with total and free plasma concentrations in healthy individuals. these effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).

objective: measurement of auc, cmax, tmax, t1/2 and clearance (cl) of the protease inhibitor kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals * establish free and total plasma - blood cell concentration-relationship * establish free and total plasma - saliva concentration-relationship * establish blood cell concentration - drug transporter expression-relationship

Eligibility criteria:
inclusion criteria: * good state of health exclusion criteria: * drug treatment with known inhibitors or inducers of cytochrome p450 isozymes or abc-transporters within the preceding 2 months * any acute or chronic illness * smoking * pregnancy * alcohol or drug abuse

Keywords: ritonavir lopinavir hiv infections
norepinephrine versus phenylephrine continuous variable infusion in cesarean delivery

Conditions: Cesarean Section Complications; Spinal Anesthesia

Summary: comparison will be conducted between continuous variable infusions of phenylephrine with starting dose of 0.75 mcg/kg/min and norepinephrine bitartrate with starting dose of 0.1 mcg/kg/min (with norepinephrine base of 0.05 mcg/kg/min) for prophylaxis against post-spinal hypotension during cesarean delivery

maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (cd). many vasopressors have been used for prevention of post-spinal hypotension (psh) during cd; however, the optimum protocol for prophylaxis is not established yet. phenylephrine (pe) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. norepinephrine (ne) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, ne is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make ne an attractive alternative to pe. in this study, the investigators will compare continuous variable infusion of both drugs (pe and ne) with doses of 0.75 mcg/kg/min and 0.05 mcg/kg/min respectively for prophylaxis against psh during cd. we used norepinephrine bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Eligibility criteria:
inclusion criteria: * full term * pregnant women * scheduled for cesarean section exclusion criteria: * pre-eclampsia * eclampsia * bleeding * cardiac dysfunction
intraperitoneal (ip) cisplatin given with paclitaxel to treat epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to determine whether intraperitoneal (ip) cisplatin combined with intravenous (iv) paclitaxel is well tolerated in women with epithelial ovarian cancer who have had neoadjuvant chemotherapy followed by initial debulking surgery.


Eligibility criteria:
inclusion criteria: * histologically proven epithelial ovarian cancer * previously received no more than 4 cycles of neoadjuvant platinum based chemotherapy, followed by debulking surgery * ecog pfs \<_ 2 * adequate haematological (absolute neutrophil count \>_ 1,500/mm3; platelets \>_ 100,000/mm3; hemoglobin \>_ 100g/l); renal (\<_ upper limit of normal) and hepatic function * age \>_ 18 years * written informed consent and the ability of the patient to co-operate with treatment and follow up exclusion criteria: * contraindication to platinum/paclitaxel chemotherapy: prior anaphylaxis to carboplatin/paclitaxel, unresolved or excessive toxicity from neoadjuvant chemotherapy. patients must not have suffered significant bone marrow suppression during prior treatment. the significance of previous treatment delay and/or dose modification is to be determined by the principle investigator on a patient-by-patient basis. * serious concomitant medical condition, which in the investigators opinion would not make the patient a good candidate for the clinical trial. * patients with a past or concomitant malignancy other than skin cancer (excluding melanoma) * patients known to be serologically positive for hepatitis b, c or hiv * history of congestive heart failure or unstable angina or those who had a myocardial infarction within the past 6 months. patients who were not expected to tolerate the hemodynamic effects of the fluid administered as part of the ip protocol. * patients who have not received chemotherapy prior to surgery * greater than 6 weeks from time of surgery to commencement of ip chemotherapy * residual disease greater than 1 cm at time of surgery. patients whom in the surgeon's opinion are candidates for such surgery may be consented preoperatively to allow intraoperative ip catheter insertion. if however the surgeon is not able to reduce the bulk of disease to less than or equal to 1 cm, patients will be removed from the study and an ip catheter should not be placed.
safety and effectiveness of care1.02 spectacle lens in myopia control

Conditions: Myopia

Summary: china is a major country in myopia, with the highest number of teenagers suffering from myopia. controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. currently. there is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. therefore, the researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in guangzhou, to test and verify the safety and effectiveness of care1.02 on myopia control compared with single-vision spectacle lens.


Eligibility criteria:
inclusion criteria: * aged 12 to 17 years; * under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 d in each eye and astigmatism of not more than 1.50 d and anisometropia of not more than 1.50 d; * best-corrected visual acuity of equal or better than 0.00 logmar (\>= 1.0 as snellen). * the intraocular pressure of 10 to 21mmhg. * volunteer to participate in this clinical trial with signature of the informed consent form. exclusion criteria: * history of eye injury or intraocular surgery; * clinically abnormal slit-lamp findings; * abnormal fundus examination; * ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; * systemic diseases causing low immunity (such as diabetes, down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); * participation of the drug clinical trial within three month and the device clinical trial within one month; * only one eye meets the inclusion criteria; * unable to have regular follow-up; * participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Keywords: myopia control
retroview colonoscope for the evaluation of colon mucosa study

Conditions: Colonic Diseases

Summary: colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions. moreover, high definition colonoscopes (hd) associated to digital chromoendoscopy had shown better results regarding adenoma and polyps detection when compared to standard non hd scopes. however, evidence shows that during standard colonoscopy many lesions could be missed, including polyps, cancer and other kind of lesions. this could be correlated to many factors and recently reports show evidence that lesions behind the folds could be missed because the limitation of a forward view examination. until know, a new auxiliary imaging device called "third eye retroscope" had demonstrated more lesions detection during colonoscopy using a retro view, but with some limitations as absence of hd vision, the need of additional equipment and the fact the device occupies the accessory channel, limiting therapeutic efficiency. recently a new hd colonoscope called "retroview" (pentax medical) has been developed. it permits visualization of colonic mucosa in forward view, in retroflex view and allows for performance of diagnostic and therapeutics in a single colonoscope.

primary outcome: to determine the safety and feasibility of the retro view during colonoscopy using retroview colonoscope. safety was measured by the number of bleeding or perforation rates as adverse event during the procedure. feasibility was measured by the number of cases that is possible to achieve a retroflexion in the colon secondary outcome: withdrawal phase time and total procedure time.

Eligibility criteria:
inclusion criteria: * undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging; and if they were able to understand and provide written consent for the procedure. exclusion criteria: * age \<18; pregnancy, included history of colon resection, known inflammatory bowel disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of chronic stricture potentially precluding complete colonoscopy, presence of diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another clinical investigation.

Keywords: retroview colonoscope retroflexion colonoscopy colonoscopy
clinical study to determine safety and efficacy of fplus for wrinkle treatment

Conditions: Facial Wrinkles and Rhytides Reduction

Summary: patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced. this study was performed in order to evaluate the efficacy and safety of the invasix fplus system, an innovative noninvasive system intended for wrinkles and rhytides treatment. subjects were treated for face wrinkles and rhytides reduction and followed for 3 months after last treatment. in order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation.


Eligibility criteria:
inclusion criteria: * subjects with mild to moderate facial wrinkles and rhytides . * males and females 21 - 65 years of age. * willingness to follow the treatment schedule, and have photographs taken. exclusion criteria: * pacemaker or internal defibrillator, or other implanted metallic or electronic device. * permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane. * avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with botox/ha/collagen/fat injections or other augmentation methods with bio-material during last 6 months. * current or history of skin cancer, or any other type of cancer, or pre-malignant moles. * severe concurrent conditions, such as cardiac disorders. * pregnancy or nursing. * impaired immune system due to immunosuppressive diseases such as aids and hiv, or use of immunosuppressive medications. * patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, may be treated only following a prophylactic regime. * poorly controlled endocrine disorders, such as diabetes. * any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash. * history of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * history of bleeding coagulopathies, or use of anticoagulants in the last 10 days. * any facial surgery performed within 12 months prior to treatment. * facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months. * having received treatment with light, laser, rf, or other devices in the treated area within 6 months. * use of isotretinoin (accutane®) within 6 months prior to treatment. * treating over tattoo or permanent makeup. * as per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
treatment of adolescent polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: a 24 week study to compare the use of metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. these approaches will be compared to placebo (a pill that contains no active substances. metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood)

polycystic ovary syndrome (pcos) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. this condition often becomes recognized at the time of puberty. the standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern. many adolescents with pcos have increased levels of insulin, a hormone that controls the body's sugar balance. these increased insulin levels may play a role in the development of polycystic ovary syndrome. there are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. metformin is one of these drugs. metformin is a drug currently used in the management of diabetes to control blood sugar. it is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Eligibility criteria:
inclusion criteria: * menstrual irregularity defined as cycle length \> 45 days * overweight as bmi \> 25 * clinical evidence of hirsuitism or acne * testosterone \> 50ng/dl exclusion criteria: * history of diabetes mellitus * history of cushing's disease * history of hyperprolactinemia * untreated hypo or hyperthyroidism * history of adrenal hyperplasia * significant renal impairment * received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study * exercise \> 10 hours per week

Keywords: polycystic ovary syndrome overweight adolescent girls irregular menstrual cycles
trastuzumab in treating patients with recurrent osteosarcoma

Conditions: Sarcoma

Summary: rationale: monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.

objectives: * determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (herceptin). * evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin. outline: this is a multicenter study. patients receive trastuzumab (herceptin) iv over 30-90 minutes weekly. treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. after approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate. patients are followed for 1 year for survival. projected accrual: approximately 20-40 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin * measurable disease * immunohistochemical evidence of 2+ overexpression of her2 patient characteristics: age: * any age performance status: * karnofsky 80-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * alt or ast less than 3 times upper limit of normal (uln) * bilirubin less than 1.5 times uln renal: * creatinine less than 1.5 times uln or * creatinine clearance greater than 60 ml/min cardiovascular: * fractional shortening at least 29% by echocardiogram or * ejection fraction at least 50% by muga * no prior cardiac dysfunction, even if presently controlled other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy * no prior anthracycline more than 450 mg/m\^2 endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no other concurrent cancer therapy

Keywords: recurrent osteosarcoma